FDA Device Intelligence
HomeDevice types › KRL

Detector, Bubble, Cardiopulmonary Bypass

FDA product code KRL · Class 2 · Cardiovascular

8
Registered devices
148
Adverse events
4
Recalls
14
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2010-10-15Terumo Cardiovascular Systems CorporationMalfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message during system set-up. In some instances, users were no
2007-09-19Terumo Cardiovascular Systems CorpFalse Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
2007-09-19Terumo Cardiovascular Systems CorpFalse Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
2007-09-19Terumo Cardiovascular Systems CorpFalse Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.